Prediction of Brain Injury in Premature Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Neurology, Women's Studies |
| Therapuetic Areas: | Neurology, Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/18/2019 |
| Start Date: | May 2016 |
| End Date: | May 2020 |
| Contact: | Christopher J. Rhee, MD |
| Email: | cjrhee@texaschildrens.org |
| Phone: | 832-826-1380 |
Diastolic Closing Margin Predicts Brain Injury in Premature Infants
Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at
high risk for developing brain injury in the first week of life. Intraventricular hemorrhage
(IVH) and periventricular leukomalacia (PVL) are the most common injuries in this group of
infants. Their incidence is inversely proportional to gestational age (GA) and birth weight
(BW). These lesions are associated with neurodevelopmental delay, poor cognitive performance,
visual and hearing impairment, epilepsy, and cerebral palsy; and instability of systemic
hemodynamics during transition from intra- to extra-uterine life and during the early
neonatal period is believed to be at their genesis. While the incidence of ultrasound-
diagnosed cystic PVL has decreased dramatically over the last 2 decades, diffuse PVL detected
by magnetic resonance imaging (MRI) is still prevalent in survivors of neonatal intensive
care. Moreover, PVL, even when non-cystic, is associated with decreased cortical complexity
and brain volume and eventual neurocognitive impairment.
Currently, clinicians lack the tools to detect changes in cerebral perfusion prior to
irreversible injury. Unfortunately, the incidence of brain injury in ELBW infants has
remained relatively stable. Once translated to the bedside, the goal of this research is to
develop a monitoring system that will allow researchers to identify infants most at risk for
IVH and PVL and in the future, intervention studies will be initiated to use the changes in
cerebral perfusion to direct hemodynamic management.
The purpose of this study is to first understand the physiology of brain injury and then to
eventually impact the outcomes in this high-risk group of infants by assessing the ability of
the diastolic closing margin (DCM), a non-invasive estimate of brain perfusion pressure, to
predict hemorrhagic and ischemic brain injury in ELBW infants. The information collected for
this study will help develop algorithms or monitoring plans that will maintain the
appropriate brain perfusion pressure and thereby, prevent severe brain injury.
high risk for developing brain injury in the first week of life. Intraventricular hemorrhage
(IVH) and periventricular leukomalacia (PVL) are the most common injuries in this group of
infants. Their incidence is inversely proportional to gestational age (GA) and birth weight
(BW). These lesions are associated with neurodevelopmental delay, poor cognitive performance,
visual and hearing impairment, epilepsy, and cerebral palsy; and instability of systemic
hemodynamics during transition from intra- to extra-uterine life and during the early
neonatal period is believed to be at their genesis. While the incidence of ultrasound-
diagnosed cystic PVL has decreased dramatically over the last 2 decades, diffuse PVL detected
by magnetic resonance imaging (MRI) is still prevalent in survivors of neonatal intensive
care. Moreover, PVL, even when non-cystic, is associated with decreased cortical complexity
and brain volume and eventual neurocognitive impairment.
Currently, clinicians lack the tools to detect changes in cerebral perfusion prior to
irreversible injury. Unfortunately, the incidence of brain injury in ELBW infants has
remained relatively stable. Once translated to the bedside, the goal of this research is to
develop a monitoring system that will allow researchers to identify infants most at risk for
IVH and PVL and in the future, intervention studies will be initiated to use the changes in
cerebral perfusion to direct hemodynamic management.
The purpose of this study is to first understand the physiology of brain injury and then to
eventually impact the outcomes in this high-risk group of infants by assessing the ability of
the diastolic closing margin (DCM), a non-invasive estimate of brain perfusion pressure, to
predict hemorrhagic and ischemic brain injury in ELBW infants. The information collected for
this study will help develop algorithms or monitoring plans that will maintain the
appropriate brain perfusion pressure and thereby, prevent severe brain injury.
This is a prospective, single-center, data collection research study for premature ELBW
infants at high risk of developing brain injury. This study is being done to evaluate the
changes in brain perfusion measured by the DCM using a comprehensive and innovative brain
monitoring platform that encompasses direct and continuous measures of cerebral blood flow
(CBF), cerebral oximetry, cerebral autoregulation, partial pressure of carbon dioxide (PCO2),
and arterial blood pressure (ABP) in the hopes to both describe the physiology of brain
injury and to correlate these findings to short- and long-term outcomes relevant to ELBW
infants.
About three hundred and ten (310) subjects are expected to be enrolled. Subjects' active
participation in the study may last up to one week and the total time they will be followed
after birth is approximately 24 months (2 years) depending on their prematurity. Information
from the subjects' medical records may be accessed, reviewed, and recorded for an additional
year after their final study visit. This study consists of about 5 study visits: Study Visit
1 (the enrollment visit - within first 6 hours of life), Study Visit 2 (occurs 2-7 days after
the enrollment visit), Study Visit 3 (occurs approximately 2-4 months Term Equivalent age/40
weeks corrected age after the enrollment visit), Study Visit 4 (occurs approximately at 12
months Corrected age after the enrollment visit), and Study Visit 5 (occurs approximately at
24 months Chronological age after the enrollment visit).
STUDY ASSESSMENTS:
- Medical and Surgical History: The subjects' detailed history will be reviewed and
recorded. The subjects' mothers will also be asked questions about their own medical
history. The mothers' medical records may also be accessed.
- Continuous Physiologic Monitoring: Monitoring will be performed that includes the
transcranial Doppler ultrasound, near-infrared spectroscopy (NIRS), and partial pressure
of carbon dioxide (PCO2) from birth to 7 days of life (visits 1 and 2).
- Ventilator: The highest daily ventilator settings and mean airway pressure (MAP) will be
reviewed and recorded from birth to 7 days of life (visits 1 and 2).
- Head Ultrasound: A head ultrasound will be performed upon enrollment (visit 1) to assess
for early and preexisting brain injury (IVH).
- Adverse Events: Any adverse events (AEs), special events of interest, or unanticipated
problems (UPs) that subjects may have experienced after enrollment will be reviewed and
recorded (visits 1, 2, 3, 4, and 5).
- Concomitant Medications: Review and record any medications of interest that subjects are
taking from birth to 7 days of life (visits 1 and 2).
- Blood Transfusions: Review and record the transfusion of blood products that are
performed on the subjects as part of standard of care from birth to 7 days of life
(visits 1 and 2).
- Echocardiogram (ECG) and Head Ultrasound: Review and record ECG and head ultrasound
results that are performed on the subjects as part of standard of care from birth to 7
days of life (visits 1 and 2).
- Respiratory Interventions and Suctioning: Review and record any respiratory
interventions and/or suctioning that are performed on the subjects as part of standard
of care from birth to 7 days of life (visits 1 and 2).
- Magnetic Resonance Imaging (MRI): Perform a MRI exam at visit 3.
- Capute Scales and Neurologic Exam: Perform this assessment at visit 4 to assess the
subjects' development and cognitive function and to provide an early evaluation for any
neurologic abnormalities that may be related to brain injury.
- Bayley-III Motor Sub-Test Exam: Perform this assessment at visit 4 to assess the
subjects' development and cognitive function and to provide an early evaluation for any
neurologic abnormalities that may be related to brain injury.
- Complete Bayley-III Exam: Perform this assessment at visit 5 to assess the subjects'
development and cognitive function and to provide an early evaluation for any neurologic
abnormalities that may be related to brain injury.
infants at high risk of developing brain injury. This study is being done to evaluate the
changes in brain perfusion measured by the DCM using a comprehensive and innovative brain
monitoring platform that encompasses direct and continuous measures of cerebral blood flow
(CBF), cerebral oximetry, cerebral autoregulation, partial pressure of carbon dioxide (PCO2),
and arterial blood pressure (ABP) in the hopes to both describe the physiology of brain
injury and to correlate these findings to short- and long-term outcomes relevant to ELBW
infants.
About three hundred and ten (310) subjects are expected to be enrolled. Subjects' active
participation in the study may last up to one week and the total time they will be followed
after birth is approximately 24 months (2 years) depending on their prematurity. Information
from the subjects' medical records may be accessed, reviewed, and recorded for an additional
year after their final study visit. This study consists of about 5 study visits: Study Visit
1 (the enrollment visit - within first 6 hours of life), Study Visit 2 (occurs 2-7 days after
the enrollment visit), Study Visit 3 (occurs approximately 2-4 months Term Equivalent age/40
weeks corrected age after the enrollment visit), Study Visit 4 (occurs approximately at 12
months Corrected age after the enrollment visit), and Study Visit 5 (occurs approximately at
24 months Chronological age after the enrollment visit).
STUDY ASSESSMENTS:
- Medical and Surgical History: The subjects' detailed history will be reviewed and
recorded. The subjects' mothers will also be asked questions about their own medical
history. The mothers' medical records may also be accessed.
- Continuous Physiologic Monitoring: Monitoring will be performed that includes the
transcranial Doppler ultrasound, near-infrared spectroscopy (NIRS), and partial pressure
of carbon dioxide (PCO2) from birth to 7 days of life (visits 1 and 2).
- Ventilator: The highest daily ventilator settings and mean airway pressure (MAP) will be
reviewed and recorded from birth to 7 days of life (visits 1 and 2).
- Head Ultrasound: A head ultrasound will be performed upon enrollment (visit 1) to assess
for early and preexisting brain injury (IVH).
- Adverse Events: Any adverse events (AEs), special events of interest, or unanticipated
problems (UPs) that subjects may have experienced after enrollment will be reviewed and
recorded (visits 1, 2, 3, 4, and 5).
- Concomitant Medications: Review and record any medications of interest that subjects are
taking from birth to 7 days of life (visits 1 and 2).
- Blood Transfusions: Review and record the transfusion of blood products that are
performed on the subjects as part of standard of care from birth to 7 days of life
(visits 1 and 2).
- Echocardiogram (ECG) and Head Ultrasound: Review and record ECG and head ultrasound
results that are performed on the subjects as part of standard of care from birth to 7
days of life (visits 1 and 2).
- Respiratory Interventions and Suctioning: Review and record any respiratory
interventions and/or suctioning that are performed on the subjects as part of standard
of care from birth to 7 days of life (visits 1 and 2).
- Magnetic Resonance Imaging (MRI): Perform a MRI exam at visit 3.
- Capute Scales and Neurologic Exam: Perform this assessment at visit 4 to assess the
subjects' development and cognitive function and to provide an early evaluation for any
neurologic abnormalities that may be related to brain injury.
- Bayley-III Motor Sub-Test Exam: Perform this assessment at visit 4 to assess the
subjects' development and cognitive function and to provide an early evaluation for any
neurologic abnormalities that may be related to brain injury.
- Complete Bayley-III Exam: Perform this assessment at visit 5 to assess the subjects'
development and cognitive function and to provide an early evaluation for any neurologic
abnormalities that may be related to brain injury.
Inclusion Criteria:
- Informed consent obtained from parent or legally authorized representative (LAR)
- Live-born ELBW infant
- Less than 6 hours of life
- Birth weight 401 to 1000g
- Admitted to Texas Children's Hospital (TCH) Pavilion for Women (PFW) Neonatal
Intensive Care Unit (NICU)
- Umbilical arterial catheter (UAC) in place
Exclusion Criteria:
- Complex congenital anomalies of central nervous system (CNS)
- Complex chromosomal congenital anomalies
- Hydrops fetalis
- Poor skin integrity
- Live-born but receiving only comfort care
- Grade 3-4 IVH by head ultrasound (HUS) at the first ultrasound completed at or before
6 hours of life
We found this trial at
3
sites
1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Phone: 832-826-1380
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
Click here to add this to my saved trials
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
Click here to add this to my saved trials
Click here to add this to my saved trials